Robustness Evaluation of a Legacy N-Glycan Profiling Method for a Therapeutic Antibody Under ICH Q14 Lifecycle Principles.

Antibodies (Basel) · 2026 · PMC12821501 · PMID 41562782

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highly significantno p-value reported

In contrast, the labeling reagent showed clear instability over time, as indicated by a high coefficient of determination (R 2 ) and highly significant p -values (< 0.05).

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